HSPP Guidance Topics

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Announcement: Revised Common Rule (Effective 1/21/19)

The documents below are currently pending review for compliance with the new Revised Common Rule. Users must also review our Revised Common Rule webpage for any alternative guidance as a result of these new regulations, based on your study's approval date. Contact your local IRB if your have any questions about a specific guidance topic.

 

 

Guidance Topics

Select Your IRB
  • Anonymous vs Confidential Data
  • Biosafety & Radiation Safety
For All IRBs
  • Business Associate Agreement Decision Tree [HIPPA / HITECH] (PDF)
For All IRBs
  • Certificates of Confidentiality (CoC)   
For All IRBs
  • Children As Research Subjects
N/A
  • Collaborative Institutional Training Initiative (CITI)
For All IRBs
  • Clinical Trials Registration
N/A
  • Closure of Studies
HealthSci N/A
  • Cognitively Impaired Persons as Research Subjects
N/A ArtSci
  • Conflict of Interest (CoI)
All IRBs
  • Conversion of Paper Studies Into eIRB (PDF) 
HealthSci N/A
  • Course Related-Student Research Assignments (Research In An Instructional Setting)
All IRBs
  • Data and Safety Monitoring
HealthSci ArtSci
  • Data Steward 
HealthSci ArtSci
  • Data Use Agreements (DUAs)
All IRBs
  • Decedent Research (Health Information of Deceased Individuals)
All IRBs
  • Disposal of Confidential Data (Coming Soon)
N/A N/A
  • Elderly / Aged Individuals As Research Subjects
N/A ArtSci
  • Emergency Use of an Investigational Drug or Biologic
HealthSci N/A
  • Engagement of Institutions in Human Subjects Research
All IRBs
  • Expired Studies
All IRBs
  • Family Educational Rights and Privacy Act (FERPA)   
All IRBs
  • FDA Audit Checklist (PDF)
HealthSci N/A
  • FDA Inspection Readiness
HealthSci N/A
  • Frequently Asked Questions (FAQ's) For Researchers
N/A ArtSci
  • General Data Protection Regulation (GDPR)

All IRBs

  • Genetic Information Nondiscrimination Act (GINA)
All IRBs
  • Genomic Research (dbGAP, NIDDK, GWAS)

All IRBs
  • Glossary 
HealthSci N/A
  • Good Clinical Practice (GCP) 
HealthSci N/A
  • Health Insurance Portability and Accountability Act (HIPAA) & Protected Health Information (PHI)
HealthSci ArtSci
  • Humanitarian Device Exemption (HDE) and Humanitarian Use Device (HUD)
HealthSci N/A
  • Information Security
HealthSci ArtSci
  • Informed Consent Process And Documentation
HealthSci ArtSci
  • Institutional Review Board (IRB)
N/A ArtSci
  • International Research
N/A ArtSci
  • Internet Research
HealthSci ArtSci
  • Investigational Drugs and Devices
HealthSci N/A
  • IRB Approval Of Research Studies
N/A ArtSci
  • IRB Authorization Agreements (IAA)
For All IRBs
  • IRB Fees
All IRBs
  • Mobile Medical Applications

All IRBs
  • Non-English Speakers As Research Subjects
All IRBs
  • Non-Human Subject Research

All IRBs

  • Pilot Studies
All IRBs
  • Pregnant Women, Fetuses, and Neonates As Research Subjects
N/A Artsci
  • Prisoners As Research Subjects
HealthSci ArtSci
  • Quality Activities and Regulatory Requirements
All IRBs
  • Recording of Human Subjects
HealthSci N/A
  • Recordkeeping and Record Retention
All IRBs
  • Records-Based Research (Coming Soon)
N/A
  • Recruitment of Subjects For Research
HealthSci ArtSci
  • Reportable Events 1: Protocol Deviations and Violations
HealthSci ArtSci
  • Reportable Events 2: Unanticipated Problems and Adverse Events  
HealthSci ArtSci
  • Research Misconduct
HealthSci N/A
  • Research Non-Compliance
HealthSci N/A
  • Research Repositories (Banks, Registries, Etc)
All IRBs
  • Research Roles and Requirements (Principal Investigator; Key Personnel; Etc) 
HealthSci ArtSci
  • Scientific Review Boards (SRB) (CINJ Only)  
HealthSci N/A
  • Site Authorization
N/A ArtSci
  • Statute Of Limitations Summary For Researchers (PDF)
All IRBs
  • Students & Employees As Research Subjects
N/A ArtSci
  • Study Management Tools
HealthSci N/A
  • Subject Compensation / Payments
N/A ArtSci
  • Surrogate Consent (Adult Subjects Who Lack The Capacity To Consent)
  • Survey Research
HealthSci N/A
  • Waiver of Informed Consent
HealthSci ArtSci

*** See Announcement: Revised Common Rule above